Elevated Vacuum Research Articles

Quantifying Bone and Skin Movement in the Residual Limb-Socket Interface of Individuals With Transtibial Limb Loss Using Dynamic Stereo X-Ray: Protocol for a Lower Limb Loss Cadaver and Clinical Study.

Relative motion between the residual limb and socket in individuals with transtibial limb loss can lead to substantial consequences that limit mobility. Although assessments of the relative motion between the residual limb and socket have been performed, there remains a substantial gap in understanding the complex mechanics of the residual limb-socket interface during dynamic activities that limits the ability to improve socket design. However, dynamic stereo x-ray (DSX) is an advanced imaging technology that can quantify 3D bone movement and skin deformation inside a socket during dynamic activities. This study aims to develop analytical tools using DSX to quantify the dynamic, in vivo kinematics between the residual limb and socket and the mechanism of residual tissue deformation. A lower limb cadaver study will first be performed to optimize the placement of an array of radiopaque beads and markers on the socket, liner, and skin to simultaneously assess dynamic tibial movement and residual tissue and liner deformation. Five cadaver limbs will be used in an iterative process to develop an optimal marker setup. Stance phase gait will be simulated during each session to induce bone movement and skin and liner deformation. The number, shape, size, and placement of each marker will be evaluated after each session to refine the marker set. Once an optimal marker setup is identified, 21 participants with transtibial limb loss will be fitted with a socket capable of being suspended via both elevated vacuum and traditional suction. Participants will undergo a 4-week acclimation period and then be tested in the DSX system to track tibial, skin, and liner motion under both suspension techniques during 3 activities: treadmill walking at a self-selected speed, at a walking speed 10% faster, and during a step-down movement. The performance of the 2 suspension techniques will be evaluated by quantifying the 3D bone movement of the residual tibia with respect to the socket and quantifying liner and skin deformation at the socket-residuum interface. This study was funded in October 2021. Cadaver testing began in January 2023. Enrollment began in February 2024. Data collection is expected to conclude in December 2025. The initial dissemination of results is expected in November 2026. The successful completion of this study will help develop analytical methods for the accurate assessment of residual limb-socket motion. The results will significantly advance the understanding of the complex biomechanical interactions between the residual limb and the socket, which can aid in evidence-based clinical practice and socket prescription guidelines. This critical foundational information can aid in the development of future socket technology that has the potential to reduce secondary comorbidities that result from complications of poor prosthesis load transmission. DERR1-10.2196/57329.

Pilot Test of a Definitive Prosthetic Socket Made with 3D Printing Technology

ABSTRACT Introduction Additive manufacturing (also known as 3D printing) as a fabrication method is ideally suited to merging the organic shapes of human anatomy with engineered components. Many early adopters are exploring the application of these technologies for the fabrication of 3D-printed sockets, but questions remain regarding the ability to fabricate strong, well-fitting definitive sockets. The goal of the present study was to examine the real-world effect of using 3D-printed sockets with regards to mobility, comfort, balance confidence, and user acceptance. Materials and Methods Nine veterans with transtibial amputations participated in the study, three each using pin, sealing sleeve, or seal-in liner for suspension. Participants had their conventional definitive socket duplicated using 3D printing. When the 3D-printed socket was ready, using their conventional socket, participants performed a 2-minute walk test, followed by socket comfort score and rating of perceived exertion (10-point scale), Prosthetic Limb Users Survey of Mobility, Activities-Specific Balance Confidence, select subscales of the Prosthesis Evaluation Questionnaire, and the Amputee Body Image Scale–Revised. After completing the baseline data, participants were fitted with the 3D-printed socket and, after using it for 2 weeks, we repeated the data collection. Results Three participants were not able to complete the study. No large differences were observed for any of the measures. Participants were generally satisfied with the fit of the 3D-printed sockets, but there were challenges with getting the 3D-printed sockets to support elevated vacuum with the sealing sleeve and seal-in liner suspension methods. Conclusions No differences in performance or user acceptance were identified for pin suspension, but the 3D-printed sockets were not able to reliably support suction or elevated vacuum; further development will be needed before they are ready for clinical application. Clinical Relevance The present study has demonstrated the ability to achieve satisfactory fit and outcomes using 3D printing to fabricate definitive prosthetic sockets, but the printing method was unable to deliver consistent air-tight sealing for suction or elevated vacuum suspension. Other 3D printing methods and some secondary processing steps may be able to correct this deficiency.

The relationship between residual limb health, motion within the socket, and prosthetic suspension.

Residual limb health is critical for continued prosthesis use; however, many prosthesis users experience skin-related breakdown. The interface between the residual limb and the prosthetic socket sets the local mechanical environment and plays a role in skin stresses. Motion of the residual limb in the socket adds additional mechanical strain on the limb. This article explores the relationship between motion of the limb in the socket and residual limb health. We evaluated current methods for assessing residual limb health and motion of the residual limb in the socket and compared these evaluations across different prosthetic suspension systems. While few direct studies comparing residual limb health and motion exist, it has been shown that elevated vacuum suspension systems result in both improved residual limb health compared to passive suction and pin-lock systems and decreased motion compared to passive suction, pin-lock, knee sleeve, and anatomical suspension systems. While motion and health have not been directly linked, elevated vacuum suspension may demonstrate a relationship that reduced motion of the residual limb in the socket improves residual limb health. Further evaluation in this area is necessary to more completely and directly understand the relationship between residual limb motion and residual limb health.

Mechanically and physiologically optimizing prosthetic elevated vacuum systems in people with transtibial amputation: a pilot study.

The most suitable elevated vacuum (EV) pressure may differ for each individual prosthesis user depending on suspension needs, socket fit, prosthetic components, and health. Mechanical and physiological effects of EV were evaluated in an effort to determine the optimal vacuum pressure for three individuals. Instrumented EV sockets were created based on the participants' regular EV sockets. Inductive distance sensors were embedded into the wall of the socket at select locations to measure limb movement relative to the socket. Each participant conducted an activity protocol while limb movement, limb fluid volume, and user-reported comfort were measured at various socket vacuum pressure settings. Increased socket vacuum pressure resulted in reduced limb-socket displacement for each participant; however, 81-93% of limb movement was eliminated by a vacuum pressure setting of 12 (approximately -9 inHg). Relative limb-socket displacement by sensor location varied for each participant, suggesting distinct differences related to socket fit or residual limb tissue content. The rate of limb fluid volume change and the change in socket comfort did not consistently differ with socket vacuum pressure, suggesting a more complex relationship unique to each individual. Practitioners may use individual responses to optimize socket vacuum pressure settings, balancing mechanical and physiological effects of EV for improved clinical outcomes.

Effects of Unity Prosthetic Elevated Vacuum Suspension System on Minimum Swing Toe Clearance.

The risk of tripping in people with amputation is greater than that of able-bodied individuals due to reduced toe clearance during the swing phase. Appropriate prosthetic suspension may increase toe clearance by providing more secured attachment between the residual limb and prosthetic socket. Research is lacking on the Unity suspension system's effect on swing toe clearance. Twelve people with transtibial amputation were fitted with the Unity suspension system. After one month accommodation period, the person walked with active (ON) or inactive vacuum (OFF) in a CAREN-Extended virtual reality system, across multiple simulated real-world scenarios. Prosthetics minimum swing toe clearance, and kinematic data, while the vacuum was ON or OFF, were compared with the intact side and a group of 12 able-bodied individuals. Minimum swing toe clearance (MSTC) and knee flexion angle were larger on the prosthetic side (active and inactive vacuum) compared to both the intact side and the control group. However, hip flexion angle on the prosthetic side was approximately 17% smaller than the control group. Unlike the control group, MSTC with active and inactive vacuum suspension was not significantly different between level walking and other walking conditions. Finally, among all walking conditions, the lowest swing toe clearance for both control and the amputee groups was recorded when the limb was at the top of a side-slope. An effective suspension system could improve toe clearance; however, significant differences were not found between active and inactive vacuum conditions. The likelihood of inappropriate foot contact on side-slope ground might be greater than other walking conditions for both able-bodied and amputee groups, possibly leading to stumbling or falling.

Modeling the mechanics of elevated vacuum systems in prosthetic sockets

Elevated vacuum (EV) is suggested to improve suspension and limb volume management for lower limb prosthesis users. However, few guidelines have been established to facilitate configuration of EV sockets to ensure their safe and proper function. A benchtop model of an EV socket was created to study how prosthetic liner tensile elasticity, socket fit, and socket vacuum pressure affect liner displacement and subsequent pressure on the residual limb. A domed carbon fiber layup was used to represent an EV socket. Inserts were used to simulate various air gaps between the socket and liner. Various prosthetic liner samples were placed under the carbon fiber layup. Liner displacement and the corresponding pressure change underneath the liner were measured as vacuum was applied between the liner sample and socket wall. Tissue vacuum pressure increased linearly with socket vacuum pressure until the liner contacted the socket wall. Predicted tissue vacuum pressure matched well with experimental results. Findings suggest that the effect of vacuum pressure on the residual limb is primarily determined by air gap distance. The developed model may be used to assess effects of EV on residual limb tissues based on an individual's socket fit, liner characteristics, and applied vacuum. Understanding the physiological effects of EV on the residual limb could help practitioners avoid blister formation and improve EV implementation.

Oxygen Consumption and Speed Performance of a Runner with Amputation Wearing an Elevated Vacuum Running Prosthesis

ABSTRACT Introduction Persons with lower-limb differences are increasingly seeking out a means to participate in sport and running activities. Suspension of the running-specific prosthesis (RSP) during high-intensity running is crucial for safety and optimal running performance. The vacuum-assisted socket system (VASS) provides enhanced proprioception and residual limb volume stability during walking; however, utilization of the VASS in an individual fit with an RSP has yet to be explored in case or empirical studies. We report outcomes of a recreational running transtibial prosthesis user wearing a novel VASS-RSP. Methods A 33-year-old man with transtibial amputation was provided an RSP with a VASS and performed outcome measures while wearing the VASS-RSP and non–VASS-RSP. He performed a series of straight and counterclockwise (CCW) curve track 40-m runs while speed gates recorded split and total time. The patient also performed a 10-minute treadmill run oxygen consumption was determined, and Socket Comfort Scores (SCS) were recorded. Results No significant differences in track running trials were observed; straight track running speeds were similar VASS (5.37 ± 0.06 m/s) and non–VASS-RSP (5.37 ± 0.16 m/s), [t(1) = 0.320, P = 0.979]. Curve track speeds improved while wearing the VASSRSP (4.72 ± 0.09 m/s) compared with the non–VASS-RSP (4.66 ± 0.03 m/s) [t(2) = 0.846, P = 0.487]. Speeds were significantly faster during straight track running (5.37 ± 0.08 m/s) than during curve track running (4.70 ± 0.07 m/s) when both RSP configurations were combined [t(4) = 15.8, P = 0.001]. Net oxygen consumption reduced while wearing VASS-RSP (24.6 mL/kg per minute) compared with non–VASS-RSP (29.2 mL/kg per minute). Socket comfort during outcome measures improved 33% while wearing the VASS-RSP. Conclusions The patient preferred using the VASS-RSP while performing running exercises, and some outcome measures comparing the two suction suspension systems support the patient values. The novel VASS system should be further tested to determine potential utility for running exercise and sport interventions for persons with amputation.

Mechanical Evaluation Of Unity Elevated Vacuum Suspension System.

Small residual limb-socket displacement is a good indicator of prosthetic suspension system quality. Active vacuum suspension systems can decrease vertical movement inside the socket, compared to non-active suction systems. This study mechanically evaluated limb-socket displacement with the Össur Unity active vacuum system. Forty-eight conditions were evaluated: four cylindrical and four conical sockets (polypropylene, polyethylene terephthalate glycol-modified (PETG), thermoset resin (acrylic), Thermolyn soft materials); two Iceross Seal-In V liners (standard, high profile); three vacuum conditions (active vacuum, inactive vacuum, no suction with valve open). An Instron 4428 test machine applied 0-100N linear ramped tensile loads to each positive mold, with the socket secured in place, while displacement between the mold and socket was recorded. Following the displacement tests, the load before failure (i.e., 10 mm displacement) was measured. Average and standard deviations for movement between the mold and sockets were small. The displacement average for all conditions was 0.30±0.16mm for active vacuum, 0.32±0.16mm for inactive vacuum, and 0.39±0.22mm for no suction. Across all trials, active vacuum systems tolerated significantly (p<0.001) more load before failure (812±221N) compared to inactive vacuum (727±213N), and no suction (401±184N). The maximum load before failure (1142±53N) was for the cylindrical polypropylene socket and high-profile liner. The Unity system successfully controlled pistoning inside the socket for regular activity loads and also controlled the greatest traction loads. While relative movement was smallest for Unity, all conditions (inactive vacuum, no suction) were viable for loads less than 100N. Furthermore, similar results can be achieved when using different socket fabrication materials.

Effectiveness of elevated vacuum and suction prosthetic suspension systems in managing daily residual limb fluid volume change in people with transtibial amputation

Previous studies investigating limb volume change with elevated vacuum have shown inconsistent results and have been limited by out-of-socket volume measurements and short, single-activity protocols. To evaluate the effectiveness of elevated vacuum for managing limb fluid volume compared to suction suspension with an in-socket measurement modality during many hours of activity. Fixed-order crossover design with a standardized out-of-laboratory activity protocol. Transtibial electronic elevated vacuum users participated in two sessions. Elevated vacuum was used during the first session, and suction suspension in the second. Participants completed a 5.5-h protocol consisting of multiple intervals of activity. In-socket residual limb fluid volume was continuously measured using a custom portable bioimpedance analyzer. A total of 12 individuals participated. Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum. Although individual results varied, 11 participants experienced lower overall rates of fluid volume loss in at least one limb region using elevated vacuum. Elevated vacuum may be more effective as a volume management strategy after accumulation of activity. Individual variation suggests the potential to optimize the limb fluid volume benefits of elevated vacuum by reducing socket vacuum pressure for some users. A better understanding of how elevated vacuum (EV) affects residual limb fluid volume will allow prosthetists to make more informed clinical decisions regarding accommodation strategies designed to improve daily socket fit.

Transtibial amputee gait with the unity suspension system

Study Design: Experimental study.Objectives: Research is lacking on the Unity suspension system’s effect on gait performance. The purpose of this study was to evaluate the effects of the Unity elevated vacuum system on level walking performance while the vacuum was active (ON) and inactive (OFF).Methods: Twelve unilateral transtibial amputees were fit with the Ossur elevated vacuum suspension system (Unity) and Pro-flex XC foot. After one month accommodation period, 3D motion analysis was performed using the CAREN-Extended system. Temporal-spatial, kinematics, and kinetics were examined during level walking to understand the effect of the elevated vacuum, separate trials were completed with the vacuum active (ON) or inactive (OFF).Results: Significant differences were found between vacuum conditions (ON and OFF) for some temporal-spatial gait parameters, but differences were very small and may not be clinically significant. Differences between vacuum conditions on most kinetic and kinematic gait parameters were also low. However, step length symmetry between intact and prosthetic limbs improved with active elevated vacuum (ON).Conclusions: Elevated vacuum suspension’s effect on level walking gait is small if a well-fitting liner-based socket is provided.Implications for rehabilitationStep length symmetry between intact and prosthetic limbs improved with an active vacuum system.Differences between vacuum conditions on most gait parameters were small during level walking.Subjective feedback showed improved proprioception and comfort with an active vacuum system.

SATISFACTION AND EXPERIENCE WITH THE UNITY SUSPENSION SYSTEM

BACKGROUND&#x0D; While elevated vacuum suspension systems have some benefits over the other suspension approaches 1–5, elevated vacuum may not be appropriate for all amputees. The Unity sleeveless vacuum suspension system was developed to overcome issues related to knee range of motion and amputees comfort 6. This study compared the Unity suspension system with suction and pin/lock systems based on user satisfaction and experience with these systems.&#x0D; Abstract PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/32030/24447&#x0D; How to cite: Gholizadeh H, Lemaire E.D, Nielen D, Lebel P. SATISFACTION AND EXPERIENCE WITH THE UNITY SUSPENSION SYSTEM. CANADIAN PROSTHETICS &amp; ORTHOTICS JOURNAL, VOLUME 1, ISSUE 2, 2018; ABSTRACT, ORAL PRESENTATION AT THE AOPA’S 101ST NATIONAL ASSEMBLY, SEPT. 26-29, VANCOUVER, CANADA, 2018.DOI: https://doi.org/10.33137/cpoj.v1i2.32030 &#x0D; Abstracts were Peer-reviewed by the American Orthotic Prosthetic Association (AOPA) 101st National Assembly Scientific Committee. &#x0D; http://www.aopanet.org/

Real time monitoring of transtibial elevated vacuum prostheses: A case series on socket air pressure.

Prosthetic elevated vacuum is a suspension method used to reduce daily volume changes of the residual limb. Evaluation of the effectiveness of these systems is limited due to a lack of correlation to actual socket air pressure, particularly during unconstrained movements. This may explain some of the variability in functional outcomes reported in the literature. Our objective was to develop a light-weight portable socket measurement system to quantify internal socket air pressure, temperature, and acceleration; and to present preliminary results from implementation with three transtibial prosthesis users with mechanical elevated vacuum pumps. Participants completed five functional tasks with and without the vacuum pumps actively connected, including the 2-Minute Walk test, 5-Times Sit-to-Stand test, 4-Square Step test, L-Test, and Figure-8 test. Results demonstrated different gait profiles and pressure ranges for each user. Two of the participants demonstrated substantially lower air pressure (higher vacuum) over time while the pump was active compared to inactive. The minimum air pressure measured for all participants was -34.6 ± 7.7 kPa. One participant did not show substantial changes in pressure over time for either pump condition. Functional task performance was not significantly different between pump conditions. Correlation with accelerometer readings indicated peak positive pressures occurred just following initial contact of the foot in early stance, and the most negative pressures (highest vacuum) were observed throughout swing. This study has demonstrated the use of a portable data logging tool that may serve the clinical and research communities to quantify the operation of elevated vacuum systems, and better understand the variability of mechanical pump operation and overall system performance.

An innovative microprocessor-based system for Human Activity Recognition: A fast and reliable classification algorithm

People with lower limb amputation may experience walking limitations on slopes because of missing musculoskeletal and neuromuscular systems. Elevated vacuum suspension could benefit transtibial amputee gait for slope walking, but research is lacking to inform clinical practice.Twelve people with unilateral transtibial amputation were fitted with the Unity elevated vacuum suspension system (Össur) and Pro-Flex XC foot. 3D motion analysis was performed for 7° incline, 7° decline, and level walking within a CAREN-Extended system virtual Park environment. Randomized and blinded walking trials were completed with the vacuum active or inactive.Statistically significant differences (p < 0.05) were found between vacuum conditions when walking uphill or downhill for temporal spatial, kinematic, and kinetic gait parameters; however, effect sizes were small (r≤0.35). Prosthetic step length decreased for both vacuum conditions on downhill compared to uphill walking. Symmetry index was <10% for step length, step time, and stance time for both vacuum condition during downhill walking, indicating acceptable symmetry. During incline walking, step length was only symmetrical with active vacuum. Knee range of motion was not restricted, for both conditions.Active vacuum improved gait symmetry for incline walking, but the other differences between vacuum conditions were small and may not be clinically significant. Therefore, the Unity system approach for elevated vacuum suspension had a positive, but small, effect on walking and should maintain appropriate walking even with vacuum failure, until limb volume changes adversely affect socket fit (i.e., elevated vacuum helps control limb volume fluctuations over time).

Transtibial amputee gait during slope walking with the unity suspension system

BackgroundPeople with lower limb amputation may experience walking limitations on slopes because of missing musculoskeletal and neuromuscular systems. Elevated vacuum suspension could benefit transtibial amputee gait for slope walking, but research is lacking to inform clinical practice. MethodsTwelve people with unilateral transtibial amputation were fitted with the Unity elevated vacuum suspension system (Össur) and Pro-Flex XC foot. 3D motion analysis was performed for 7° incline, 7° decline, and level walking within a CAREN-Extended system virtual Park environment. Randomized and blinded walking trials were completed with the vacuum active or inactive. ResultsStatistically significant differences (p < 0.05) were found between vacuum conditions when walking uphill or downhill for temporal spatial, kinematic, and kinetic gait parameters; however, effect sizes were small (r≤0.35). Prosthetic step length decreased for both vacuum conditions on downhill compared to uphill walking. Symmetry index was <10% for step length, step time, and stance time for both vacuum condition during downhill walking, indicating acceptable symmetry. During incline walking, step length was only symmetrical with active vacuum. Knee range of motion was not restricted, for both conditions. ConclusionActive vacuum improved gait symmetry for incline walking, but the other differences between vacuum conditions were small and may not be clinically significant. Therefore, the Unity system approach for elevated vacuum suspension had a positive, but small, effect on walking and should maintain appropriate walking even with vacuum failure, until limb volume changes adversely affect socket fit (i.e., elevated vacuum helps control limb volume fluctuations over time).

Effects of the unity vacuum suspension system on transtibial gait for simulated non-level surfaces.

Walking on various surfaces encountered in everyday life requires lower limb prosthesis users to continually adapt their movement patterns. Elevated vacuum suspension systems could improve transtibial amputee gait on non-level surfaces; however, research is lacking to guide clinical practice. Twelve transtibial amputees were fitted with the Össur sleeveless vacuum suspension system (Unity). After a one month accommodation period, the CAREN-Extended system was used to evaluate gait on a self-paced treadmill when walking with continuous perturbations (medial-lateral translations, rolling hills, simulated uneven ground) with an active or inactive vacuum suspension system. Significant differences between active and inactive vacuum conditions (p<0.05) were found for some temporal-spatial and kinematic gait parameters, but the differences were small and not considered clinically significant. Our findings suggest that potential vacuum pump failures would not immediately affect gait performance in a moderately high functioning amputee population. However, residual limb volume changes over time due to the removal of elevated vacuum may adversely affect socket fit, leading to greater gait differences and reduced quality of life.

Progress Toward Optimizing Prosthetic Socket Fit and Suspension Using Elevated Vacuum to Promote Residual Limb Health.

Objective: Prosthetic sockets are custom made for each amputee, yet there are no quantitative tools to determine the appropriateness of socket fit. Ensuring a proper socket fit can have significant effects on the health of residual limb soft tissues and overall function and acceptance of the prosthetic limb. Previous work found that elevated vacuum pressure data can detect movement between the residual limb and the prosthetic socket; however, the correlation between the two was specific to each user. The overall objective of this work is to determine the relationship between elevated vacuum pressure deviations and prosthetic socket fit. Approach: A tension compression machine was used to apply repeated controlled forces onto a residual limb model with sockets of different internal volume. Results: The vacuum pressure-displacement relationship was dependent on socket fit. The vacuum pressure data were sensitive enough to detect differences of 1.5% global volume and can likely detect differences even smaller. Limb motion was reduced as surface area of contact between the limb model and socket was maximized. Innovation: The results suggest that elevated vacuum pressure data provide information to quantify socket fit. Conclusions: This study provides evidence that the use of elevated vacuum pressure data may provide a method for prosthetists to quantify and monitor socket fit. Future studies should investigate the relationship between socket fit, limb motion, and limb health to define optimal socket fit parameters.

Vacuum level effects on knee contact force for unilateral transtibial amputees with elevated vacuum suspension

The elevated vacuum suspension system (EVSS) has demonstrated unique health benefits for amputees, but the effect of vacuum pressure values on knee contact force (KCF) is still unclear. The objective of this study was to investigate the effect of vacuum levels on KCF for unilateral transtibial amputees (UTA) using the EVSS. Three-dimensional gait was modeled for 9 UTA with five vacuum levels (0–20inHg [67.73kPa], 5inHg [16.93kPa] increments) and 9 non-amputees based on kinematic and ground reaction force data. The results showed that the vacuum level effects were significant for peak axial KCF, which had a relatively large value at 0 and 20inHg (67.73kPa). The intact limb exhibited a comparable peak axial KCF to the non-amputees at 15inHg (50.79kPa). At moderate vacuum levels (5inHg [16.93kPa] to 15inHg [50.79kPa]), co-contraction of quadriceps and hamstrings at peak axial KCF was similar for the intact limb, but was smaller for the residual limb comparing with the non-amputees. The intact limb showed a similar magnitude of quadriceps and hamstrings force at 15inHg (50.79kPa) to the non-amputees, but the muscle coordination patterns varied between the residual and intact limbs. These findings indicate that a proper vacuum level may partially compensate for the lack of ankle plantarflexor and reduce the knee loading. Of the tested vacuum levels, 15inHg (50.79kPa) appears most favorable, although additional analyses with more amputees are suggested to confirm these results prior to establishing clinical guidelines.

Vacuum level effects on gait characteristics for unilateral transtibial amputees with elevated vacuum suspension

BackgroundThe elevated vacuum suspension system has demonstrated unique health benefits for amputees, but the effect of vacuum pressure values on gait characteristics is still unclear. The purpose of this study was to investigate the effects of elevated vacuum levels on temporal parameters, kinematics and kinetics for unilateral transtibial amputees. MethodsThree-dimensional gait analysis was conducted in 9 unilateral transtibial amputees walking at a controlled speed with five vacuum levels ranging from 0 to 20inHg, and also in 9 able-bodied subjects walking at self-preferred speed. Repeated ANOVA and Dunnett's t-test were performed to determine the effect of vacuum level and limb for within subject and between groups. FindingsThe effect of vacuum level significantly affected peak hip external rotation and external knee adduction moment. Maximum braking and propulsive ground reaction forces generally increased for the residual limb and decreased for the intact limb with increasing vacuum. Additionally, the intact limb experienced an increased loading due to gait asymmetry for several variables. InterpretationThere was no systematic vacuum level effect on gait. Higher vacuum levels, such as 15 and 20inHg, were more comfortable and provided some relief to the intact limb, but may also increase the risk of osteoarthritis of the residual limb due to the increased peak external hip and knee adduction moments. Very low vacuum should be avoided because of the negative effects on gait symmetry. A moderate vacuum level at 15inHg is suggested for unilateral transtibial amputees with elevated vacuum suspension.

Elevated vacuum suspension preserves residual-limb skin health in people with lower-limb amputation: Randomized clinical trial.

ClinicalTrials.gov; "Evaluation of limb health associated with a prosthetic vacuum socket system": NCT01839123; https://clinicaltrials.gov/ct2/show/NCT01839123?term=NCT01839123&rank=1.

Dynamic Effectiveness Evaluation of Elevated Vacuum Suspension

Dynamic Effectiveness Evaluation of Elevated Vacuum Suspension